Monday, June 26, 2017
QuintilesIMS to buy DrugDev
QuintilesIMS to buy DrugDev
Melinta Therapeutics, a privately held company focused on discovering, developing, and commercializing novel antibiotics to treat serious bacterial infections, has announced that the U.S. Food and Drug Administration (FDA) has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations.
Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, has announced that data showing the non-inferiority of NEPA (netupitant/palonestron) versus a 3-day oral aprepitant (APR)/granisetron (GRAN) regimen, have been accepted for presentation at the upcoming Multinational Association of Supportive Care in Cancer (MASCC/ISOO) Congress, on June 22-24 2017.
Neurotech Pharmaceuticals, Inc., in collaboration with the Lowy Medical Research Institute (LMRI), has announced 24-month results demonstrating that NT-501 delivering Ciliary Neurotrophic Factor (CNTF) has a beneficial effect in patients with Macular Telangiectasia type 2 (MacTel). The multicenter, randomized clinical trial demonstrated a statistically significant reduction in the progressive loss of photoreceptors in treated versus untreated eyes. NT-501 utilizes the Company’s proprietary Encapsulated Cell Therapy (ECT) platform that can be customized to deliver specific therapeutic molecules to the back of the eye for retinal disease.
CNS-centric CRO matching service launches
Pfizer and Eli Lilly announced that the FDA has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP). Tanezumab is an investigational humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor (NGF). It is the first NGF inhibitor to receive Fast Track designation, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.
Mithra, a company dedicated to Women’s Health, has received Orphan Drug Designation (ODD) for E4 in Neonatal Encephalopathy (NE). Mithra intends to develop E4 to treat Hypoxic Ischemic Encephalopathy (HIE), a subset of NE which accounts for 50-80% of cases and affects pre-term and new born babies (>36 weeks gestation).
Exelixis announced the initiation of the dose-escalation stage of a phase Ib trial of cabozantinib in combination with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic urothelial carcinoma (UC) or renal cell carcinoma (RCC). The primary objective is to determine the optimal dose and schedule of daily oral administration of cabozantinib when given in combination with atezolizumab to inform the trial’s subsequent expansion stage.
Outsourcing drug development to Asia: An increasingly lucrative strategy
Eye on Alzheimer’s disease